FDA Grants Breakthrough Device Designation to AI-Enabled Diagnostic for Kidney Disease

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By : dLife Editors

Renalytix AI, a company developing of artificial intelligence-enabled clinical diagnostics for kidney disease, announced that it has been granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA), for its lead diagnostic product.

It is the first such designation for an AI-enabled diagnostic for kidney disease by any company.

The device, dubbed KidneyIntelX is designed to diagnose and improve the clinical management of patients with Type 2 diabetes with fast-progressing kidney disease.

“This designation is a significant advancement towards our goal of bringing to market a solution that can greatly improve the identification and treatment of patients with chronic kidney disease,” says Sally Bowden, chief operating officer, RenalytixAI. “We look forward to continuing to work closely with the FDA through this process, including on our data development plan, our clinical validation and our subsequent submission for regulatory clearance.”

Developers are hopeful the device will curtail the estimated $114 billion annual cost of chronic and end-stage kidney disease to the United States healthcare system.

The diagnostic will use machine learning algorithms to assess the combination of predictive blood-based biomarkers, in combination with electronic health record information, to identify progressive kidney disease.

KidneyIntelXTM is being developed in close collaboration with the Mount Sinai Health System.

“We’re pleased RenalytixAI has received Breakthrough Designation for KidneyIntelX, providing the opportunity to work hand-in-hand with the FDA towards the goal of FDA submission,” says Dr. Erik Lium, executive vice president of Mount Sinai Innovation Partners. “Renal disease represents an increasing healthcare crisis globally, and early detection and intervention are essential in changing the course of this disease.”

The FDA’s Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.

The goal of the program is to provide patients and health care providers with timely access to these medical devices by speeding up their development, assessment, and review while preserving the statutory standards for premarket approval, 510(k) clearance and De Novo marketing authorization, consistent with the Agency’s mission to protect and promote public health.



  1. FDA Grants Breakthrough Device Designation to KidneyIntelX™. (2019, May 2). PR Newswire. Retrieved: https://prnmedia.prnewswire.com/news-releases/fda-grants-breakthrough-device-designation-to-kidneyintelx-300842413.html